Status:
UNKNOWN
Hepatocellular Carcinoma in Patients With a Cirrhosis Due to an Alcoholic or a Non Alcoholic Fatty Liver Disease
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
Global prevalence of Non Alcoholic Fatty Liver Diseases (NAFLD) ranges from 22% to 28%.The spectrum of these hepatic abnormalities extends from isolated steatosis to steatohepatitis (Non Alcoholic Ste...
Eligibility Criteria
Inclusion
- Group 1
- Inclusion Criteria :
- Available social insurance
- Signed consent for the study enrollment
- Age ≥ 18 years
- Exclusion Criteria :
- Patients in the group with metabolic fatty liver with hepatocellular carcinoma
- Alcohol consumption ≤ 30 g/d (or 210 g/week) in men and ≤ 20 g/d (or 140 g/week) in women.
- Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and of adjacent liver in routine practice.
- No systemic HCC treatment in the previous 6 months
- Group 2
- Inclusion Criteria :
- Available social insurance
- Signed consent for the study enrollment
- Age ≥ 18 years
- Exclusion Criteria :
- Patients in the group with metabolic fatty liver without hepatocellular carcinoma
- Alcohol consumption ≤ 30 g/d (or 210 g/week) in men and ≤ 20 g/d (or 140 g/week) in women.
- Decision (less than 3 months) to perform a liver biopsy in routine practice. Liver biopsy will be organized because of one or more liver abnormalities and/or fatty liver seen at liver ultrasound due to the current lack of validated non-invasive marker of inflammation, cellular death and fibrosis in these patients.
- Group 3
- Inclusion Criteria :
- Available social insurance
- Signed consent for the study enrollment
- Age ≥ 18 years
- Exclusion Criteria :
- Patients with an alcoholic liver disease with hepatocellular carcinoma
- Alcohol consumption \> 30 g/d (or 210 g/week) in men and \> 20 g/d (or 140 g/week) in women.
- Decision (less than 3 months) to perform a liver biopsy of a tumor suspect of HCC and of adjacent liver in routine practice.
- No systemic HCC treatment in the previous 6 months
- Group 4
- Inclusion Criteria :
- Available social insurance
- Signed consent for the study enrollment
- Age ≥ 18 years
- Exclusion Criteria :
- Patients with an alcoholic liver disease without hepatocellular carcinoma
- Alcohol consumption \> 30 g/d (or 210 g/week) in men and \> 20 g/d (or 140 g/week) in women.
- Decision (less than 3 months) to perform a liver biopsy in routine practice. No systemic HCC treatment in the previous 6 months. Liver biopsy will be organized because of one or more liver abnormalities and/or fatty liver seen at liver ultrasound due to the current lack of validated non-invasive marker of inflammation, cellular death and fibrosis in these patients.
Exclusion
Key Trial Info
Start Date :
February 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03307408
Start Date
February 28 2017
End Date
February 1 2020
Last Update
October 11 2017
Active Locations (1)
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1
CHU de Nice
Nice, France, 06000